Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Topiramate 100mg;
Teva Pharma (New Zealand) Limited
Topiramate 100 mg
100 mg
Film coated tablet
Active: Topiramate 100mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Opadry Yellow 85G32313 Magnesium stearate Mannitol Microcrystalline cellulose Pregelatinised maize starch
Prescription
Hetero Drugs Limited
Topiramate Actavis is indicated in adults and children. Topiramate Actavis tablet range is not suitable for any children weighing less than 25 Kg and is not suitable as monotherapy for children or adolescents weighing less than 50 kg. - as monotherapy in patients with newly diagnosed epilepsy - for conversion to monotherapy in patients with epilepsy - as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.
Package - Contents - Shelf Life: Blister pack, Alu/Alu bottom strip with Alu/PVC/PVDC blisters in printed carton - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Alu bottom strip with Alu/PVC/PVDC blisters in printed carton - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Alu bottom strip with Alu/PVC/PVDC blisters in printed carton - 200 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with HDPE twist off cap with integrated dessicant - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with HDPE twist off cap with integrated dessicant - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with HDPE twist off cap with integrated dessicant - 200 tablets - 36 months from date of manufacture stored at or below 25°C
2013-06-05
NEW ZEALAND CONSUMER MEDICINE INFORMATION TOPIRAMATE ACTAVIS TOPIRAMATE TOPIRAMATE TABLETS 25 MG, 50 MG, 100 MG AND 200 MG WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TOPIRAMATE - ACTAVIS Tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking TOPIRAMATE - ACTAVIS against the benefits they expect it will have for you. If you have any concerns about taking this medicine, talk to your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT TOPIRAMATE - ACTAVIS IS USED FOR TOPIRAMATE, the active ingredient in TOPIRAMATE - ACTAVIS Tablets, is used for the treatment of various types of epilepsy in adults and children over 2 years of age**, and for the prevention of migraine in adults. It prevents seizures and migraines by acting on the nerves and chemicals in the brain. Your doctor may prescribe TOPIRAMATE - ACTAVIS on its own, or in addition to another medicine for controlling your seizures or migraines. Your doctor may have prescribed TOPIRAMATE - ACTAVIS for another reason. Ask your doctor if you have any questions about why TOPIRAMATE - ACTAVIS has been prescribed for you. There is no evidence that TOPIRAMATE - ACTAVIS is addictive. TOPIRAMATE - ACTAVIS is available only with a doctor’s prescription. _** Topiramate Actavis tablet range cannot deliver lower doses required for younger paediatric _ _patients (See the data sheet for further information on this). _ BEFORE YOU TAKE TOPIRAMATE - ACTAVIS _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE TOPIRAMATE - ACTAVIS IF YOU ARE ALLERGIC TO MEDICINES CONTAINING TOPIRAMATE, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body lumpy skin rash (“hives”), Đọc toàn bộ tài liệu
Version 1.2 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Topiramate Actavis 25, film-coated tablets 25 mg Topiramate Actavis 50, film-coated tablets, 50 mg Topiramate Actavis 100, film-coated tablets, 100 mg Topiramate Actavis 200, film-coated tablets, 200 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg topiramate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 25 mg – White, round, biconvex, film coated tablet marked with ‘V1’. 50 mg – Light yellow, round biconvex, film coated tablet marked with ‘V3’. 100 mg – Yellow, round biconvex film, coated tablet marked with ‘V4’. 200 mg – Salmon, oval biconvex, film coated tablet marked with ‘V5’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EPILEPSY Topiramate Actavis is indicated in adults and children 2 years and over**: • as monotherapy in patients with newly diagnosed epilepsy • for conversion to monotherapy in patients with epilepsy • as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome. ** Topiramate Actavis tablet range cannot deliver lower doses required for younger paediatric patients (See section 4.2 DOSE AND METHOD OF ADMINISTRATION ). MIGRAINE Topiramate Actavis is indicated in adults for the prophylaxis of migraine headache. The usefulness of Topiramate Actavis in the acute treatment of migraine headache has not been studied. 4.2 DOSE AND METHOD OF ADMINISTRATION Topiramate Actavis Tablets should be swallowed whole. Topiramate Actavis Tablets can be taken with or without food. For optimum seizure control in both adults and children, it is recommended that therapy should be initiated at a low dose followed by slow titration to an effective dose. Dose titration should be guided by clinical outcome. The recommended dosages of Topiramate Actavis in adults and children with epilepsy are listed as follows and summarised in Table 1. EPILEPSY - MONOTHERAPY In newly diag Đọc toàn bộ tài liệu